Recall database

W L Gore & Associates, Inc. recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–4 of 4 recalls

Class IIOngoingZ-2915-2026

W L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

W L Gore & Associates,…AZAug 19, 2026

Class IIOngoingZ-2914-2026

W L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

W L Gore & Associates,…AZAug 19, 2026

Class IIOngoingZ-2672-2026

W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…

Due to catheter separation

W L Gore & Associates,…AZJul 8, 2026

Class IIOngoingZ-0036-2026

W L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft

Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising;…

W L Gore & Associates,…AZOct 8, 2025